Clinical Trials

IBD and Stress Research Study For Teens and their Families

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a family-based research study (sometimes referred to as a clinical trial or clinical study), to look at treatment adherence (follow-through with treatment recommendations like taking medications), and how stress might affect adherence and quality of life in teenagers with inflammatory bowel disease (IBD).

Who can participate?

Families with a teenager between the ages of 13 and 17 years old who has been diagnosed with Crohn’s Disease, ulcerative colitis or indeterminate colitis and is currently receiving treatment for IBD may be eligible to participate. (The family may include one parent, two parents or a guardian.)

Ages

  • From 13 To 17  years old

Conditions

  • Crohn's Disease and Colitis
  • Gastroenterology, Hepatology and Nutrition
  • Mental Health

What is involved?

The study will last for approximately 6 months and includes 2 study visits. Visit 1 will take approximately 1 hour, as well as visit 2 which will take place 6 months after visit 1. The following is a list of some of the procedures that will take place during the study:

Your child will:

    • Have information about their disease symptoms, etc. obtained from his/her medical chart 
    • Complete questionnaires about his/her mood and qualify of life 
    • Be interviewed about his/her recent adherence to treatment recommendations (taking medications, etc.)
    • Have an intravenous (IV) blood draw for tests (6-TGN test, CBC, ESR, and albumin) if these were not done during his/her clinic visit

You will: 

    • Complete questionnaires about your basic family information, your child’s mood and quality of life, etc. 
    • Be interviewed about your child’s recent adherence to treatment recommendations (taking medications, etc.)

What are the benefits?

If you and your child agree to participate in this research study, the information learned from this study may benefit patients by helping health care professionals understand factors that affect disease management better. Information from this study will be used to design and test interventions aimed at improving patient and family adjustment to IBD, disease management skills, and quality of life in patients with this disease and their families.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian and the child have reviewed and signed this form.

Do participants receive pay, compensation or reimbursement?

Families will receive up to $50 for their time and effort.

Who should I contact for more information?

Liz Hente
Elizabeth.hente@cchmc.org
513-803-0920
Adherence Psychology
Cincinnati Children’s Hospital Medical Center

Principal Investigator

Kevin A. Hommel, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center

Date

Ongoing